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MICROSTAR Colposcope R00

by Ecleris 3 variants

Ref U1C100A5Model C100A

MICROSTAR Colposcope R00 (U1C100A5) is a colposcope (EU MDR Class I; FDA Class II; FDA product code HEX, Colposcope (And Colpomicroscope)) made by Ecleris, registered in EUDAMED on 3 Jun 2026 (Basic UDI-DI ++B366U1COLPOSCOPESY9), cleared under FDA 510(k) K100595 on 9 Jul 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI B366U1C100A5R000), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K100595

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++B366U1COLPOSCOPESY9 Basic UDI-DI B366U1C100A5R000UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberB366U1C100A5R000 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK100595 Date9 Jul 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++B366U1COLPOSCOPESY9 registered 3 Jun 2026 Active
  • FDA 510(k) K100595 decided 9 Jul 2010 Active
  • FDA GUDID UDI-DI B366U1C100A5R000 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K100595
  2. Listed FDA GUDID B366U1C100A5R000
  3. Registered EUDAMED ++B366U1COLPOSCOPESY9

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Colposcope EUDAMED
MICROSTAR Colposcope GUDID
Generic name
Colposcope
Model / Ref / Catalog
C100A, U1C100A5, R00
Primary DI / UDI-DI
B366U1C100A5R000
Basic UDI-DI
++B366U1COLPOSCOPESY9
Direct marketing DI
B366U1C100A5R000
510(k) Number
FDA product code
HEX
EMDN code
Z12020703 Colposcopes
GMDN term
Colposcope
Device class
Class I EUDAMED
Class II GUDID
Regulation number
884.1630
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
C100A
U1C100A5
GUDID
R00
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Colposcope

Cleared under the same submission (K100595)

and 8 more cleared under K100595

Similar devices in this category

Other devices filed under COLPOSCOPES.

Other devices from Ecleris

See all devices from Ecleris →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)